Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer: ARTemis Trial.

Earl, H.M., Hiller, L., Dunn, J.A., Blenkinsop, C., Grybowicz, L., Vallier, A-L., Gounaris, I., Abraham, J.E., Hughes-Davies, L., McAdam, K., Chan, S., Ahmad, R., Hickish, T. F., Rea, D., Caldas, C., Bartlett, J.M.S., Cameron, D.A., Provenzano, E., Thomas, J., Hayward, R.L. and ARTemis Investigators Group, , 2017. Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer: ARTemis Trial. Annals of Oncology, 28 (8), 1817 - 1824.

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DOI: 10.1093/annonc/mdx173

Abstract

Background: The ARTemis trial previously reported that addition of neoadjuvant bevacizumab (Bev) to docetaxel (D) followed by fluorouracil, epirubicin and cyclophosphamide (D-FEC) in HER2 negative breast cancer improved the pathological complete response (pCR) rate. We present disease-free survival (DFS) and overall survival (OS) with central pathology review. Patients and methods: Patients were randomized to 3 cycles of D followed by 3 cycles of FEC (D-FEC), ±4 cycles of Bev (Bev + D-FEC). DFS and OS were analyzed by treatment and by central pathology reviewed pCR and Residual Cancer Burden (RCB) class. Results: A total of 800 patients were randomized [median follow-up 3.5 years (IQR 3.2-4.4)]. DFS and OS were similar across treatment arms [DFS hazard ratio (HR)=1.18 (95% CI 0.89-1.57), P = 0.25; OS HR = 1.26 (95% CI 0.90-1.76), P = 0.19). Both local pathology report review and central histopathology review confirmed a significant improvement in DFS and OS for patients who achieved a pCR [DFS HR = 0.38 (95% CI 0.23-0.63), P < 0.001; OS HR = 0.43 (95% CI 0.24-0.75), P = 0.003]. However, significant heterogeneity was observed (P = 0.02); larger improvements in DFS were obtained with a pCR achieved with D-FEC than a pCR achieved with Bev + D-FEC. As RCB class increased, significantly worse DFS and OS was observed (P for trend <0.0001), which effect was most marked in the ER negative group. Conclusions: The addition of short course neoadjuvant Bev to standard chemotherapy did not demonstrate a DFS or OS benefit. Achieving a pCR with D-FEC is associated with improved DFS and OS but not when pCR is achieved with Bev + D-FEC. At the present time therefore, Bev is not recommended in early breast cancer. ClinicalTrials.gov number: NCT01093235.

Item Type:Article
ISSN:0923-7534
Uncontrolled Keywords:ARTemis ; bevacizumab ; breast cancer ; neoadjuvant chemotherapy
Group:Faculty of Health & Social Sciences
ID Code:29821
Deposited By: Unnamed user with email symplectic@symplectic
Deposited On:03 Oct 2017 13:33
Last Modified:03 Oct 2017 13:33

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